Cell Therapeutics' Jan. 17 bid to buy Miami-based DOR BioPharma signals a move by the Seattle company to broaden its reach in products that ameliorate the negative effects of cancer treatment, CEO James Bianco said in an interview with "The Pink Sheet" DAILY.

DOR's investigational product orBec (oral beclomethasone dipropionate) is a treatment for gastrointestinal Graft-versus-Host disease therapy.

"What we're trying to do is build a more integrated portfolio and relaunch a commercial presence in the U.S. alongside our existing portfolio of products, as well as others that fit synergistically with it," Bianco said. DOR's "oral beclomethasone product candidate would fit our mission."

Bianco said CTI "took the chance on the offer" despite the fact DOR's GVHD therapy missed its primary endpoint in a registration trial, because of the clinical benefits the therapy showed in other study data (¹ Also see "DOR Biopharma’s orBec For GI Disease Misses Primary Endpoint" - Pink Sheet, 25 January, 2007.).

"We certainly understand from a risk perspective about missing primary endpoints," Bianco said.

CTI's investigational lung cancer therapy Xyotax (paclitaxel poliglumex) has done poorly in trials thus far as the company has successively narrowed the target patient population to a new study that includes only women with normal estrogen levels (² Also see "Cell Therapeutics Files For SPA On New Xyotax Study" - Pink Sheet, 10 January, 2007.).

Gastrointestinal GVHD occurs in up to 60 percent of patients who receive allogeneic hematopoietic stem cell or bone marrow transplants either after high-dose chemotherapy or as a therapy for blood cancers, according to DOR.

"Allogeneic transplants are probably about half of the bone marrow or stem cell transplants being done," Bianco said. "It can be a very effective therapy" for blood cancers.

"The growth actually has been predominantly in stem cells or umbilical cord - those are the two areas that have been showing about a 5 percent versus a 2 percent year over year growth."

The other half of hematopoietic stem cell transplants are autologous transplants that supplement high-intensity chemo, Bianco said.

CTI "cut [its] teeth on the bone marrow transplant community, so we know the issues that these patients address," Bianco said. "We certainly know all of the centers and have either trained with or have trained a number of the directors of the bone marrow transplant programs throughout the U.S. and Europe."

In a letter of intent accompanying the unsolicited DOR offer, Bianco pointed out another advantage of aligning with CTI: the company's development deal with Novartis for Xyotax (³ Also see "Novartis Signs Development Deal With Cell Therapeutics For Xyotax" - Pink Sheet, 18 September, 2006.). As part of the agreement "Novartis has agreed to fund a CTI sales force of 35," Bianco writes. "CTI would prioritize the label expansion and commercial development of orBec as a synergistic product in our haematology portfolio."

In addition to the possibility of acquiring orBec for its hematology line-up, CTI has pixantrone, an anthracycline for non-Hodgkin's lymphoma that is "coming up on Phase III news later this year," Bianco said.

"We're also looking at one other small licensing opportunity for a support care product in the oncology space."

DOR, meanwhile, has signed a letter of intent with Sigma-Tau Pharmaceuticals in Gaithersburg, Md., to negotiate a "possible business transaction or strategic alliance regarding orBec." That exclusive agreement expires March 1, and DOR CEO Christopher Schaber has said he will not talk to CTI before then, though he has publicized the CTI offer.

Separately, on Jan. 23, CTI and the U.S. Attorney's Office reached a tentative agreement on allegations that the company illegally received Medicare reimbursements for off-label uses of Trisenox (arsenic trioxide). CTI says it was depending on a third-party reimbursement firm at the time.

CTI and USAO reached an "oral agreement in principal" under which the company will make a single payment of $10.5 million in return for the government dropping its claims, according to documents filed with the Securities & Exchange Commission.

CTI makes no "admission of wrongdoing" in the provisional settlement

In 2004, the government began an investigation of CTI's promotional practices for Trisenox, a leukemia drug the company sold to the Fraser, Pa., company Cephalon in 2005 for $71.9 million (⁴ Also see "Cephalon To Develop Oncology Franchise Following Acquisition Of CTI’s Trisenox" - Pink Sheet, 13 June, 2005.).

- Shirley Haley (s.haley@elsevier.com)

Cell Therapeutics CEO James Bianco: An Interview With “The Pink Sheet” DAILY

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